SHS Webinar "From Algorithm to Approved: Navigating AI & ML in Medical Devices"
September 3, 2026
Online, 4:00 – 5:30 PM
AI is transforming healthcare - but turning an intelligent algorithm into a market-ready medical device is a regulatory challenge in its own right. Join Dr. Dirk Hueber and Nik Bartlett as they break down the requirements for developing and sustaining AI/ML-based medical devices, covering everything from regulatory landscape to development to post-market obligations. Bring your questions for an open Q&A at the end.
Speakers
Dr. Dirk Hueber
With a passion for solving problems, Dirk was originally a Theoretical Physicist, spending 13 years undertaking scientific research. His move into the MedTech, IVD and Pharma industry and finally into consulting led him to work with companies large and small, established and start-ups. Since July 2019, Dirk has been applying his 20 years of experience in leadership positions in quality functions to his role as Head of Quality and eHealth at Congenius.
Nik Bartlett
Nik has worked as a Technology Consultant within the Congenius eHealth team since February 2022. He holds a BEng (Hons) in Electronic Engineering and an MSc in Data Communications from Brunel University in London and has over 25 years’ experience in product and software development. Nik has worked across a wide variety of technology sectors on a diverse range of products - including medical devices and systems, data communications and voice over data, network attached storage, custom systems for superyachts, smart metering (CNI and IoT), automotive electronics, and cybersecurity. Having held roles spanning all levels, from developer to head of engineering, Nik has a proven track record of delivering projects adhering to complex standards and guidelines.
About Congenius
Congenius provides tailored MedTech consultancy services in the Quality, Regulatory, eHealth, Operations, and Clinical fields. By sharing knowledge and expertise with start-ups in the medical device and in vitro diagnostics industry, they form trusted partnerships that enable the smartest route to enhanced medical solutions.
If you do not see the ticket form, please reload the page or click here.